Business Overview and History
Cardiff Oncology is a clinical-stage biotechnology company at the forefront of developing novel therapies to combat a range of cancers. The company's lead asset, onvansertib, is a highly selective Polo-like Kinase 1 (PLK1) inhibitor that has demonstrated promising results in various clinical trials. Cardiff Oncology's strategic focus on PLK1 inhibition, a well-validated oncology drug target, has positioned the company as a leader in the fight against some of the most challenging cancer types.
Cardiff Oncology was originally incorporated in Florida in 2002 and later re-incorporated in Delaware in 2010, changing its name to Trovagene, Inc. In May 2012, the company's common stock was listed on The Nasdaq Capital Market under the ticker symbol TROV. In May 2020, the company underwent another name change to Cardiff Oncology, Inc., and its Nasdaq ticker symbol changed to CRDF to better reflect its strategic focus on developing cancer therapies.
The company's journey began with a legacy portfolio of intellectual property related to cancer diagnostics. However, in 2017, Cardiff Oncology made a pivotal move by licensing the global development and commercialization rights to onvansertib from Nerviano Medical Sciences. This acquisition of the PLK1 inhibitor marked a significant shift in the company's strategic direction, as it sought to leverage the potential of this well-validated oncology target to develop novel cancer treatments.
Under the leadership of CEO Mark Erlander, Cardiff Oncology has made substantial progress in advancing onvansertib through various clinical trials. The company's pipeline currently focuses on evaluating onvansertib in combination with standard-of-care (SOC) therapies for the treatment of metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple-negative breast cancer (TNBC).
In 2023, Cardiff Oncology reached a significant milestone by completing enrollment in a Phase 1b/2 single-arm clinical trial evaluating onvansertib in combination with FOLFIRI and bevacizumab in second-line KRAS-mutated metastatic colorectal cancer. The data from this trial was subsequently published in a peer-reviewed journal, the Journal of Clinical Oncology, in October 2024, further validating the potential of onvansertib in this indication.
Financial Performance and Liquidity
As a clinical-stage biotechnology company, Cardiff Oncology has not yet generated significant revenue from product sales. For the fiscal year ended December 31, 2024, the company reported total revenue of $683,000, primarily from royalty payments on its legacy intellectual property portfolio. This represents a 40% increase from the $488,000 in revenue reported in the prior year.
The company's financial performance has been characterized by net losses, as it continues to invest heavily in the development of onvansertib. For the fiscal year ended December 31, 2024, Cardiff Oncology reported a net loss of $45.43 million, compared to a net loss of $41.44 million in the previous year. This increase in net loss was primarily driven by higher research and development expenses, which grew from $32.86 million in 2023 to $36.85 million in 2024, as the company advanced its clinical programs.
In the fourth quarter of 2024, Cardiff Oncology reported revenue of $151,000, a 10% increase from $137,000 in the same quarter of the previous year. However, the net loss for Q4 2024 increased to $11.79 million from $9.10 million in Q4 2023, primarily due to increased R&D expenses related to the advancement of the company's clinical programs.
Despite the ongoing net losses, Cardiff Oncology maintains a strong liquidity position. As of December 31, 2024, the company had $91.7 million in cash, cash equivalents, and short-term investments, which it believes will be sufficient to fund its operations into the first quarter of 2027. This liquidity position was bolstered by a $40 million underwritten registered direct offering that the company completed in December 2024, attracting participation from new and existing healthcare-dedicated investors.
Cardiff Oncology's financial health is further evidenced by its strong balance sheet ratios. The company's debt-to-equity ratio stands at a low 0.018, indicating minimal leverage. Both the current ratio and quick ratio are 7.08, reflecting the company's ability to meet its short-term obligations comfortably. It's worth noting that Cardiff Oncology currently operates exclusively in the United States market.
For the full year 2024, Cardiff Oncology reported an annual operating cash flow of -$37.69 million and an annual free cash flow of -$37.77 million, reflecting the company's continued investments in research and development.
Onvansertib: The Lead Drug Candidate
Onvansertib, Cardiff Oncology's lead drug candidate, is a highly selective and potent PLK1 inhibitor with a favorable pharmacokinetic profile, including a 24-hour half-life. The company's strategic focus on PLK1 inhibition is based on the well-validated role of this oncology target in regulating cell division and proliferation, making it a promising approach for disrupting tumor growth.
One of the key advantages of onvansertib is its selectivity for the PLK1 enzyme, with minimal activity against other PLK family members (PLK2 and PLK3). This selectivity, combined with the drug's oral bioavailability and manageable safety profile, has positioned onvansertib as a potential game-changer in the treatment of various cancer types.
Onvansertib has demonstrated synergistic effects when administered in combination with different chemotherapies and targeted therapies in preclinical studies. This attribute has been crucial in Cardiff Oncology's strategy to develop onvansertib as a combination therapy across multiple solid tumor indications.
Clinical Development and Regulatory Milestones
Cardiff Oncology has made significant strides in advancing onvansertib through its clinical development pipeline. The company's lead program is the ongoing CRDF-004 trial, a randomized Phase 2 study evaluating onvansertib in combination with standard-of-care (FOLFIRI or FOLFOX plus bevacizumab) as a first-line treatment for patients with RAS-mutated metastatic colorectal cancer (mCRC).
In December 2024, Cardiff Oncology reported highly encouraging initial data from the CRDF-004 trial. The results showed that patients receiving the 30mg dose of onvansertib in combination with SOC demonstrated a 64% objective response rate (ORR), compared to a 33% ORR in the control arm. Importantly, the 30mg onvansertib arm also exhibited deeper tumor regressions, with the five deepest tumor regressions across the entire trial being observed in patients receiving the 30mg dose.
These positive findings have bolstered Cardiff Oncology's confidence in its registrational strategy for onvansertib in mCRC. The company plans to engage with the FDA in the near future to discuss the path forward, including the potential for an accelerated approval pathway similar to the one recently utilized by Pfizer for its BRAF-mutant mCRC therapy, encorafenib.
As of early 2025, Cardiff Oncology has closed the CRDF-004 trial to new patients entering screening and expects to complete enrollment of the 90 evaluable patients in the coming weeks. The company plans to release additional clinical data from the CRDF-004 trial in the first half of 2025, which will be crucial in shaping the future development and potential regulatory submission for onvansertib in first-line RAS-mutated mCRC.
Beyond the mCRC program, Cardiff Oncology is also supporting investigator-initiated trials evaluating onvansertib in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple-negative breast cancer (TNBC). These trials are designed to further explore the broad potential of onvansertib in addressing unmet needs across various cancer indications.
Intellectual Property and Competitive Landscape
Cardiff Oncology has been proactive in strengthening its intellectual property portfolio to protect the commercial potential of onvansertib. In the fourth quarter of 2024, the company announced the issuance of a new U.S. patent, which covers the method of using onvansertib in combination with bevacizumab for the treatment of KRAS-mutated mCRC patients who have not previously been treated with bevacizumab. This patent aligns with the target patient population of the company's lead mCRC program and has an expected expiration date of no earlier than 2043.
The competitive landscape for PLK1 inhibitors in oncology has been relatively limited. The most advanced PLK1 inhibitor to reach late-stage clinical development was Boehringer Ingelheim's volasertib, which failed to meet its primary endpoint in a Phase 3 trial for acute myeloid leukemia. In contrast, Cardiff Oncology's onvansertib has demonstrated a more favorable safety profile and increased selectivity for the PLK1 target, potentially giving it an advantage over previous generations of PLK1 inhibitors.
Risks and Challenges
As a clinical-stage biotechnology company, Cardiff Oncology faces several risks and challenges common to the industry. The company's success is largely dependent on the continued development and eventual regulatory approval of onvansertib. Any setbacks or delays in the clinical trials or regulatory processes could have a significant impact on the company's financial performance and future prospects.
Additionally, Cardiff Oncology operates in a highly competitive and rapidly evolving oncology landscape, where it must compete with both established pharmaceutical companies and other innovative biotechnology firms. The company's ability to differentiate onvansertib and secure favorable market positioning will be crucial to its long-term success.
Another key risk factor is the company's reliance on third-party manufacturers and service providers for the production and testing of onvansertib. Any disruptions or quality issues in the supply chain could potentially delay the clinical development and commercialization of the drug candidate.
Lastly, as a clinical-stage company, Cardiff Oncology will need to continue accessing capital markets to fund its ongoing operations and future growth initiatives. Adverse market conditions or investor sentiment could make it challenging for the company to raise the necessary capital to support its development efforts.
Outlook and Conclusion
Cardiff Oncology has positioned itself as a promising player in the oncology space with its lead drug candidate, onvansertib. The company's focus on PLK1 inhibition, combined with the favorable clinical data and safety profile of onvansertib, has garnered significant interest from the investment community and the broader healthcare industry.
The upcoming months will be pivotal for Cardiff Oncology as it looks to build on the positive initial results from the CRDF-004 trial and engage with regulators to chart the path forward for onvansertib's potential accelerated approval in first-line RAS-mutated mCRC. The planned release of additional clinical data from the CRDF-004 trial in the first half of 2025 will be a critical milestone in this process.
Additionally, the investigator-initiated trials in other cancer indications, such as mPDAC, SCLC, and TNBC, will provide further opportunities to showcase the versatility and therapeutic potential of the company's lead asset.
As Cardiff Oncology continues to advance its clinical programs and strengthen its intellectual property portfolio, the company's ability to navigate the regulatory landscape and successfully commercialize onvansertib will be critical to its long-term success. With a strong balance sheet, providing runway into the first quarter of 2027, and a promising pipeline, Cardiff Oncology appears poised to make a meaningful impact in the fight against cancer.